Method and apparatus for orthopedic implant

ABSTRACT

A tibial implant may include a plurality of implant subunits. The implant subunits may be configured for individual insertion within a wedge-shaped-void of the tibia. The implant subunits may further be configured for assembly in order to provide an implant substantially covering an exposed portion of cortical bone formed when performing a surgical osteotomy. Methods and kits for insertion and assembly of implants are further described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/705,022, filed Dec. 5, 2019, which is a continuation of PCTInternational Patent Application No. PCT/US2019/041518 filed Jul. 12,2019, titled “Method and Apparatus for Orthopedic Implant,” which claimspriority to U.S. Provisional Patent Application No. 62/697,824 filedJul. 13, 2018, also titled “Method and Apparatus for OrthopedicImplant.” The full disclosure of each of the aforementioned patentapplications is herein fully incorporated by reference.

FIELD

This application relates to methods, apparatuses, and kits forperforming tibial osteotomies and repairs of the knee.

BACKGROUND

Generally, osteotomies of the knee are designed to adjust the geometryof the knee, thereby rebalancing articular forces on the knee joint dueto the patient's arthritic disease. For example, forces may beredistributed from one side of the knee joint to another in order toalleviate pain caused by knee degeneration with resultant structuralabnormalities. In order to accomplish these objectives, a transverse cutis made in the tibia, and either distraction with interposition graftingor removing a wedge of bone is performed. Thus, the alignment of thetibia with respect to the femur and knee joint may be adjusted. The bonemay then be secured in this position. For example, bone may be securedin place by screwing metal plates to the bones and/or by inserting oneor more sections of structural material, such as a graft of hard bonetaken from an iliac crest. In such procedures, only a portion of thewedge-like-cut-out may be filled with hard bone. For example, hard bonemay be positioned adjacent a medial side of the wedge-like-cut-out andpartially inserted therein such that it may be in contact with only alimited section of cortical bone in the wedge-like-cut-out of thepatient's tibia. However, a significant amount of the wedge-like-cut-outmay remain unsupported or insufficiently supported with structuralmaterial generally designed to maintain the separation of bony surfacesand to encourage bone growth. Present designs in use are insufficientfor supporting loads associated with patients with morbid obesity(BMI>40). Accordingly, the patient may be left with only insufficientstructural support during healing causing the operation to fail.

While osteotomies have proven to be valuable in providing relief forcertain patients suffering from joint degeneration and other jointabnormalities of the knee, the procedure may be challenging for both thepatient and surgeon. Notably, the surgeon may find it difficult toproperly execute an osteotomy without substantially damaging thesurrounding tissues adjacent the tibia and knee. In addition, onlylimited structural support may be provided by the structural material.Some patients, such as obese patients, may find it particularlydifficult to successfully recover from a tibial osteotomy. Accordingly,patient recovery may tend to be slow, difficult, and painful.

Accordingly, there is a need for surgical methods and related implantsand surgical kits designed for effective insertion of implants withinthe tibia and/or positioning of the implants therein while minimizingassociated tissue damage for the patient. There is further a need formethods that provide improved mechanical support in the cut-out sectionsof the tibia, speeding recovery for patients and minimizing structuralfailures. There is further a need for methods for treating kneedegeneration and/or correcting abnormalities in the knee that may beapplicable for use in patients, such as obese patients, who may beineligible for other types of surgical intervention, and who may be atincreased risk of post-surgical complications and incomplete recoveryfrom surgery, especially following total knee replacement.

SUMMARY

In some embodiments, generally U-shaped portions of an implant forinsertion into a wedge-shaped void of a patient's tibia are described.The U-shaped portion of an implant may include a plurality of implantsubunits, the plurality of implant subunits configured to form agenerally U-shaped portion of an implant when the plurality of implantsubunits are combined. The plurality of implant subunits may further beconfigured for individual insertion into a surgical opening adjacent awedge-shaped void in a patient's tibia. The U-shaped portion of animplant may be configured to overlap a substantial area of an exposedregion of cortical bone created when forming said wedge-shaped void. Forexample, the U-shaped portion of an implant may cover an area that isgreater than about 75% of the area of the exposed region of corticalbone. The implant may further include one or more cables attached to atleast a group of implant subunits among the plurality of implantsubunits, the one or more cables configured such that when the one ormore cables are tightened, the group of implant subunits may beautomatically positioned to form the U-shaped portion of an implant.

In some embodiments, a surgical opening for insertion of implantsubunits may be significantly reduced as compared to a minimum sizedopening sized for insertion of an implant suitable for substantiallyfilling said wedge-shaped void. Moreover, the individual subunits may bereadily positioned around the rim of hard cortical bone adjacent thewedge-shaped void. For example, a system of one or more cables may bedesigned to automatically position implant subunits in a desiredconfiguration. Thus, in some embodiments, a surgeon may both insert theimplant subunits using incisions sized to minimize trauma and assemblean implant quickly and without extensive manual manipulation of implantsubunit once generally positioned within the wedge-shaped void, such asmay otherwise be required if a surgeon were manually positioning eachsubunit individually to a final position or if the surgeon wereinserting a pre-formed implant already sized to cover an exposed rim ofcortical bone.

In some embodiments, an implant may further be constructed to withstandloads associated with patients who may be obese or morbidly obese. Forexample, in some embodiments, an implant may be assembled from aplurality of implant subunits, the implant subunits configured to covera substantial area of an exposed region of cortical bone. In someembodiments, implant subunits may further be made of carbon-fiber orcarbon-fiber reinforced PEEK. In some embodiments, implant subunits maycomprise a carbon-fiber scaffold, including, for example, an internallyformed scaffold, an externally formed scaffold, or a combination ofboth. Thus, implants herein may be configured for both reduced damageduring insertion and/or positioning, and the implants may be configuredto provide immediate and improved support during healing. In someembodiments, obese patients, including patients who weigh up to about300 pounds to about 500 pounds may be surgically treated using implantsand methods described herein. In some embodiments, implants and methodsherein may be used to surgically treat patients without substantiallycompromising adjacent regions of tissue which can complicate othersurgical procedures which a patient may be eligible for in the future,such as total knee replacement.

In some embodiments, kits for performing a surgical repair of the tibiaare described herein. The kits may include a plurality of implantsubunits; wherein the plurality of implant subunits are configured forindividual insertion into a wedge-shaped void of tibial bone; whereinthe plurality of implant subunits are further configured for arrangementwith respect to one another in order to form a generally U-shapedportion of an implant, the U-shaped portion configured to substantiallycover an exposed rim of cortical bone on the periphery of thecross-section. The kits may further include one or more linking members;and instructions for how to assemble said plurality of implant subunitsinto said implant using the one or more linking members.

In some embodiments, kits for performing a surgical repair of the tibiaare described herein. The kits may include a plurality of implantsubunits; wherein the plurality of implant subunits are configured forindividual insertion of implant subunits into a wedge-shaped void oftibial bone; wherein the plurality of implant subunits are furtherconfigured for arrangement with respect to one another in order to forman implant shaped to substantially cover an exposed rim of cortical bonedefined by the wedge-shaped void. The kits may further include one ormore linking members; and instructions for how to connect the pluralityof implant subunits to the one or more linking members and how toautomatically position the implant subunits in order to form the implantwhen tightening the one or more linking members; wherein the pluralityof implant subunits include a plurality of implant subunits configuredfor bearing a patient's weight, the plurality of implant subunitscomprising a substantially hollow carbon-cage.

In some embodiments, methods for performing a surgical repair of thetibia are described herein. The methods may include creating an openingin a patient's tissue in order to expose a portion of the patient'stibia; cutting a portion of the patient's tibia to create a wedge-shapedvoid in the patient's tibia; individually inserting each of a pluralityof implant subunits through the opening in the patient's tissue; andpositioning the implant subunits within the wedge-shaped void in orderto form a generally U-shaped portion of an implant.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an anterior view of a right knee joint and surrounding anatomyshowing a wedge-like-section removed from a patient's tibia.

FIG. 2 is an anterior view of the knee joint shown in FIG. 1 with agenerally U-shaped implant inserted within the patient's tibia andstabilized medially with a metal fixation plate.

FIG. 3 is a medial perspective view of a patient's knee during part of asurgical osteotomy and repair procedure.

FIG. 4 is a perspective cross-section view of the lower portion of thetibia taken in the direction of arrow A-A indicated in FIG. 1 showing anexposed upper surface of the tibia formed by making a wedge-shaped voidtherein and a remaining hinge portion of the tibia.

FIG. 5 is a top plan view of the cross-section of the tibia shown inFIG. 4.

FIG. 6 shows the exposed upper surface of the tibia and hinge portion ofremaining bone (as shown in FIG. 5) together with implant subunits and afirst embodiment of one or more cables.

FIG. 7 shows the exposed upper surface of the tibia and hinge portion ofremaining bone (as shown in FIG. 5) together with implant subunits and asecond embodiment of one or more cables.

FIG. 8 shows the exposed upper surface of the tibia and hinge portionshown in FIG. 5 together with an embodiment of implant subunits and pinsor screws for securing the implant subunits together.

FIG. 9 is an enlarged view of the Region A in FIG. 8 indicating animplant width and thickness of cortical bone in a rim portion of anexposed surface of the tibia.

FIG. 10 shows a top plan view of implant subunits in an embodiment forassembling an implant.

FIG. 11 shows a side perspective view of an embodiment of a generallyU-shaped implant for use in a surgical repair of the knee.

FIG. 12 shows a side perspective view of an embodiment of an implant foruse in a surgical repair of the knee.

FIG. 12A shows a side perspective view of an embodiment of a ring-shapedimplant for use in a surgical repair of the knee.

FIG. 13 shows a side perspective view of another embodiment of animplant for use in a surgical repair of the knee.

FIG. 14 shows an implant subunit and positioning of the subunit during apart of a surgical repair of the knee.

FIG. 15 is a side perspective view of a first embodiment of an implantsubunit.

FIG. 16 is a side perspective view of a second embodiment of an implantsubunit.

FIG. 17 is a side perspective view of a third embodiment of an implantsubunit.

FIG. 18 is a side perspective view of an implant subunit and apparatusfor linking the implant subunit to another implant subunit and/or to aportion of a patient's bone.

FIG. 19 is a side perspective view of two implant subunits linkedtogether using a pin.

FIG. 20 is a side perspective view of two implant subunits linkedtogether using a pin and further attached to a portion of a patient'sbone.

FIG. 21 is a perspective view of a kit for making an implant from aplurality of subunits.

FIG. 22 is a perspective view of a generally U-shaped implant formed bypositioning the plurality of subunits shown in FIG. 21.

FIG. 23 is a flowchart of a method for inserting an implant into asection of a patient's tibia to perform an opening wedge osteotomy.

FIG. 24 is a flowchart of another method for inserting an implant into asection of a patient's tibia.

DETAILED DESCRIPTION

The following terms as used herein should be understood to have theindicated meanings.

When an item is introduced by “a” or “an,” it should be understood tomean one or more of that item.

“Comprises” means includes but is not limited to.

“Comprising” means including but not limited to.

“Having” means including but not limited to.

Where a range of values is described, it should be understood thatintervening values, unless the context clearly dictates otherwise,between the upper and lower limits of that range, and any other statedor intervening value in other stated ranges, may be used withinembodiments described herein.

The methods, kits, and apparatuses described herein are generallyrelated to surgical techniques for performing tibial osteotomies andinserting implants into the voids created by the osteotomies. Themethods, kits, and apparatuses described herein may be used for treatingknee joint degenerative conditions and/or other abnormalities. In someembodiments, the methods, kits, and apparatuses described herein may bespecifically designed for patients (e.g., morbidly obese patients) whomay have decreased eligibility for other types of surgical intervention,such as total or partial knee replacement, and/or who may be atincreased risk of post-surgical complications and compromised recoveryfrom surgery with previously existing methods.

During a tibial osteotomy, one or more incisions may be made below thepatient's knee joint in order to create an opening exposing thepatient's tibia. The one or more incisions may be sufficient in size tocreate an opening in the patient's tissue suitable to access tibial boneand to allow a surgeon to cut into the patient's tibia and form awedge-like void section therein, sometimes referred to herein as awedge-shaped void. For example, FIG. 1 shows an anterior view of a kneejoint and associated anatomical structures. As shown therein, awedge-shaped void 10 may be made in the tibia 12. For example, atransverse cut may be made in the tibia and a force may be applied toseparate the exposed surfaces. In some embodiments, wedge-shaped void 10may be formed slightly below an upper portion 14 of the tibia and withina lower portion 16 of the tibia. The wedge-shaped void 10 may include amedial side generally defining a wedge height H and a lateral side whichmay be tapered. Additional anatomical structures associated with theknee joint and shown in FIG. 1 include the femur 18 and patella (kneecap) 20. The fibula is not shown for clarity.

Formation of wedge-shaped void 10 may allow a surgeon to adjust thepatient's anatomy so that abnormal forces related to the patient'sdisease progression are changed in the direction of equalizing medialand lateral tibial joint forces. Following this adjustment, as shown inFIG. 2, an implant (such as exemplary generally U-shaped implant 22 oranother implant described herein) may be positioned within wedge-shapedvoid 10 so that the adjusted or preferred anatomy is substantiallymaintained during healing. In some embodiments, implants herein may begenerally U-shaped implants (such as may include a curved generallyU-shaped implant, shaped so that the implant may generally follow acontour of a section of cortical bone exposed when making a wedge-shapedvoid), ring-shaped, or other suitable shape. In the embodiment shown inFIG. 2, the generally U-shaped implant 22 may be made from a pluralityof implant subunits, including, for example, the implant subunits 24,26, and 28, discussed in further detail herein in relation to FIG. 6,for example. Once generally U-shaped implant 22 is positioned inwedge-shaped void 10, a metal retaining plate 30 may be secured to tibia12 across the gap with screws 32, 38 for example, to help keep the gapfrom opening up and keep the implant 22 in place.

FIG. 3 shows a patient's knee during a part of a surgical osteotomy andrepair procedure. As shown therein, a surgeon may create a surgicalopening 34 through the skin and other soft tissue in a region near apatient's knee in order to expose a portion of the patient's tibia 12. Asurgeon may further create a wedge-shaped void 10 in the tibia. Forexample, a surgeon may make a cut in the tibia 12 and apply a force toseparate the bone in order to create wedge-shaped void 10. In someembodiments, surgical saws, files and/or wedges may be shaped, sizedand/or otherwise suitably configured to facilitate creation of awedge-shaped void 10 using an opening 34 of reduced dimension comparedto the size of an implant to be inserted into the void 10. Accordingly,damage to patient tissues, including, for example, tissue 36 near oradjacent the opening 34, may be reduced or minimized while creating thewedge-shaped void 10. As described below, some embodiments of methodsherein may further be designed to minimize damage to patient's tissuesin other steps in performing an osteotomy, such as when inserting,positioning, and/or securing implant subunits together, or anycombinations of the aforementioned steps.

For example, in some embodiments of methods herein, a surgeon mayindividually insert a plurality of implant subunits, such as exemplaryimplant subunit 24 (insertion of which is indicated by dashed arrow 38),to fully or in-part fill in wedge-shaped void 10. The implant subunitsmay be substantially reduced in size as compared to the overall size ofa corresponding implant assembled therefrom. For example, in someembodiments, implant subunits described herein may individually subtendan area that is reduced by about 10% to about 70% as compared to an areasubtended by an implant made from the implant subunits collectively ifsuch an implant were inserted as a whole. Accordingly, in someembodiments, a surgeon may be able to insert the plurality of implantsubunits within wedge-shaped void 10 using an opening 34 of reducedsize.

An implant may then be made or assembled by positioning the insertedplurality of implant subunits in order to form the implant. In someembodiments, an implant may be assembled from implant subunits, whereinthe implant subunits are configured to support a weight of an obese or amorbidly obese patient when the implant subunits are positioned andsecured together within a wedge-shaped void 10. To facilitate support, agroup of implant subunits may be configured for positioning adjacent toand substantially covering an exposed area of hard cortical bone withinthe wedge-shaped void 10. In addition, implant subunits may beconstructed and formed of a material suitable to withstand forces neededto support an obese or morbidly obese patient. For example, in someembodiments, implant subunits may be made from or may include acarbon-fiber. In some embodiments, a carbon-fiber may be used togetherwith one or more other biocompatible materials to form a carbon-fibercomposite. In some embodiments, an implant subunit may comprise acarbon-fiber scaffold, including, for example, an internally formedscaffold, an externally formed scaffold, or a combination thereof. Thus,implants herein may be configured for both reduced damage duringinsertion and/or positioning of implant subunits, and the implants maybe configured to provide immediate and improved support during healing.

In some embodiments, at least some of the positioned implant subunitsmay further be linked together to increase the stability of an implant.For example, as shown in FIG. 3, exemplary implant subunit 24 mayinclude one or more cables 40. As described further in relation to FIG.6 and FIG. 7, the one or more cables 40 may be linked or attached todifferent implant subunits and tightened in order to link the implantsubunits together. In some embodiments, as a surgeon inserts individualimplant subunits, the one or more cables 40 may be tightened asnecessary to help position or link implant subunits together. In someembodiments, a surgeon may insert a group of implant subunits and thenuse one or more cables to tighten the inserted implant subunitstogether, thereby forming a secured implant or part of an implant.Insertion and positioning of implant subunits may also be accomplishedin stages. For example, at least some of a group of implant subunits maybe inserted and positioned in order to create a part of an implant.Additional implant subunits may then be inserted and positioned in oneor more additional stages, such as further described below in relationto FIG. 6.

FIG. 4 is a perspective cross-sectional view of the lower portion 16 ofthe tibia taken in the direction of arrow A-A indicated in FIG. 1. Asshown therein, formation of wedge-shaped void 10 may expose an uppersurface 42 of the tibial bone. The exposed upper surface 42 may includea rim 44 of hard cortical bone and an interior portion 46 of exposedtrabecular bone, the interior portion 46 of exposed trabecular bonebeing considerably weaker than the cortical bone of rim 44. Internalstructures of the interior portion 46 of exposed trabecular bone are notshown for clarity. A hinge portion 48 of tibial bone, which may or maynot be present, is also shown in FIG. 4. If present, the thickness ofhinge portion 48 may depend, for example, upon where an implant ispositioned, properties of the bone, and the amount of correctionrequired in surgery. FIG. 5 is a plan view of the lower portion 16 ofthe tibia taken in the direction of arrow A-A indicated in FIG. 1showing the exposed upper surface 42 and the remaining hinge portion 48of tibial bone.

In some embodiments, insertion and positioning of implant subunits maybe accomplished in one or more stages. For example, FIG. 6 shows theexposed upper surface 42 and remaining hinge portion 48 (also shown inFIGS. 4 and 5) together with implant subunits (24, 26, 28, 50, 52, and54) partially positioned during an intermediate stage in making agenerally curved U-shaped implant 22. For example, implant subunits (24,26, 28, 50, 52, and 54) may be inserted through opening 34 and generallypositioned on the upper surface 42 of the exposed tibia. The subunits50, 52, and 54 may be generally positioned and one or more cables 40(e.g., one or more cables internally threaded within subunits therein)may be engaged or pulled to assist in securing the implant subunits (50,52, and 54) together. In some embodiments, the one or more cables may beattached internally or externally to one or more of the subunits (24,26, 28, 50, 52, and 54) using one or more fasteners, holes, hooks, orcombinations thereof. For example, the one or more cables 40 may beattached so that when the one or more cables 40 are tightened, forcesare directed on the implant subunits (50, 52, and 54) to automaticallypull the subunits in order to achieve a desired alignment, such as acurled alignment following a part of generally U-type shape. In someembodiments, adjacent faces of the implant subunits (50, 52, and 54) maybe angled or shaped to encourage correct relative positioning of theimplant subunits (50, 52, and 54) and/or to minimize risk that anyimplant subunits may buckle or twist inappropriately. Additionalsubunits 24, 26, and 28 may then be generally positioned and the one ormore cables 40 further tightened to help align and/or secure thesubunits 24, 26, and 28. For example, to tighten the one or more cables40, one or more free ends 56 of the one or more cables 40 may be pulledsuitably taut to help align and/or secure additional subunits 24, 26,and 28 together with the implant subunits 50, 52, and 54. The suitablytaut cable may then be crimped in order to form generally U-shapedimplant 22.

In some embodiments, all of the implant subunits (24, 26, 28, 50, 52,and 54) of generally U-shaped implant 22 may be generally positioned onthe upper surface 42. One or more cables 40 may further be attached tothe implant subunits (24, 26, 28, 50, 52, and 54). For example, the oneor more cables 40 may be attached to the implant subunits (24, 26, 28,50, 52, and 54) during insertion and/or positioning. Alternatively, theone or more cables may be attached to all or some group of the implantsubunits (24, 26, 28, 50, 52, and 54) prior to insertion. For example,the one or more cables 40 may be internally threaded, hooked, or both tothe implant subunits (24, 26, 28, 50, 52, and 54). Once all of thesubunits are inserted and generally positioned on the upper surface 42,a surgeon may engage one or more free ends 56 of the one or more cables40. The implant subunits (24, 26, 28, 50, 52, and 54) may be attached tothe one or more cables 40 such that when a surgeon pulls on the freeends 56 of the one or more cables 40 adjacent subunits may be directedtogether so as to automatically achieve a desired shape, such as agenerally U-type shape. In some embodiments, adjacent faces of theimplant subunits (24, 26, 28, 50, 52, and 54) may be angled or shaped toencourage correct relative positioning of the implant subunits (24, 26,28, 50, 52, and 54) and/or to minimize risk that any implant subunitsmay buckle or twist in an inappropriate manner.

In other embodiments, one or more cables 40 may be threaded or otherwiseattached to subunits of a generally U-shaped implant 22 in othersuitable ways. In addition, the one or more cables 40 may further besecured or crimped in one or more alternative or additional positions tohelp secure subunits in order to stabilize a generally U-shaped implant22.

For example, FIG. 7 shows the top of exposed upper surface 42 togetherwith implant subunits (24, 26, 28, 50, 52, and 54) in another embodimentfor linking the subunits of a generally U-shaped implant 22. In theembodiment shown in FIG. 7, two separate groups of one or more cablesare used to stabilize generally U-shaped implant 22. For example, afirst group of one or more cables 58 may be threaded through each of thesubunits 24, 26, and 28. A second group of one or more cables 60 may bethreaded through each of the subunits 50, 52, and 54. Following generalpositioning of subunits, the first cable group 58 and second cable group60 may be pulled, separately or together, to help position and/orstabilize the subunits (24, 26, 28, 50, 52, and 54) in order to formgenerally U-shaped implant 22.

More generally, in some embodiments herein, one or more cables may beused to secure one or more implant subunits that may be positionedlaterally with respect to one or more medially positioned implantsubunits. For example, one or more laterally positioned subunits may bepositioned or secured together first. After positioning and/or securingthe laterally positioned implant subunits in place, one or more mediallypositioned implant subunits may then be positioned or secured in place,such as by forcing the one or more medially positioned implant subunitstogether with the one or more medially positioned implant subunits bypulling on free ends of one or more cables. A remaining section of cablemay then be crimped and cut to a desired length if necessary.Advantageously, in some of those embodiments, a surgeon may have readyaccess to free ends of cables because the free ends may be positionednear the medial end of wedge-shaped void 10, a position which is nearthe opening 34 where manipulation of cables may be more easilyaccomplished. Some of those embodiments may, therefore, simplify thesurgery, reduce time, and minimize risk of damage to patient tissueswhile positioning and/or securing implant subunits together.

FIG. 8 shows another embodiment for securing generally U-shaped implant22. As shown in FIG. 8, a generally U-shaped implant 22 may be securedusing one or more pins or screws 62. Pins or screws 62 may, for example,extend through one or more subunits of generally U-shaped implant 22. Insome embodiments, the one or more pins or screws 62 may further extendthrough one or more sections of adjacent bone (as also shown in FIG.20).

As shown in each of FIGS. 6-8, a generally U-shaped implant 22 may beconfigured to overlap with a substantial area of exposed rim 44 of hardcortical bone. Thus, in contrast to other implants, such as implantsinvolving use of autografts, where a significant amount of rim 44 mayremain unsupported by hard material or only insufficiently supportedwith matrix material, generally U-shaped implant 22 (and other implantsherein) may be configured to engage hard cortical bone substantiallythroughout wedge-shaped void 10. For example, in some embodiments, aplurality of implant subunits (e.g., a plurality of subunits ofexemplary U-shaped implant 22 or other implants herein) may be insertedwithin a wedge-shaped void 10 and positioned over rim 44 to covergreater than about 50%, greater than about 75%, greater than about 95%,or up to about 100% of the exposed area of rim 44. Referring to FIG. 9,which is an enlarged view of Region A in FIG. 8, in some embodiments,generally U-shaped implant 22 may be characterized by an implant width(W). In FIG. 9, to better show the overlap of implant subunit 24 and rim44, a portion of the interior boundary of rim 44 underneath implantsubunit 24 is shown as dot-dash line 45. The outer boundary 43 of rim 44may substantially overlap with the outer boundary of implant subunit 24.In some embodiments, the implant width W may be at least as wide as thethickness (T) of cortical bone. For example, in some embodiments, animplant width may range from about 1.2 times to about 2.5 times thethickness of cortical bone (T). The implant subunits 24, 26, 28, 50, 52,and 54 of U-shaped implant 22 may be constructed, secured, andpositioned over a substantial area of the exposed rim 44 to increasesupport and strengthen generally U-shaped implant 22 so that it maysupport a weight of an obese or morbidly obese patient. Furthermore,significant support may be present during times immediately followingsurgery.

In some embodiments, areas of wedge-shaped void 10 that are not filledby a generally U-shaped implant 22 may be filled with one or morefilling materials, which may be osteointegrative materials, for example.For example, regions of wedge-shaped void 10 that are not occupied bygenerally U-shaped implants 22 may be filled with one or more fillingmaterials suitable to provide additional structural support, includingsupport suitable for minimizing risk of displacement of implantsubunits. The one or more filling materials may further be configured topromote processes including osteogenesis, osteoinduction,osteoconduction, minimize risk of infection, and any combinationthereof. For example, in some embodiments, portions of wedge-shaped void10 not filled by U-shaped implant 22 may be filled with demineralizedbone matrix, hydroxyapatite, one or more growth factors, other suitablematrix materials, and any combination thereof.

In some embodiments, areas of wedge-shaped void 10 that are not filledby generally U-shaped components or portions of an implant may be filledby one or more secondary implant subunits, such as some of the implantsubunits described herein with respect to generally U-shaped implants(22, 76). And, in some embodiments, generally U-shaped implants (22, 76)described herein may function as generally U-shaped portions of animplant, which may or may not include one or more secondary implantsubunits. Secondary implant subunits, which may be configured forpositioning adjacent interior portion 46 of exposed upper surface 42,may generally not experience the same stresses as implant subunitspositioned adjacent rim 44. Accordingly, in some embodiments, secondaryimplant subunits may be configured differently than implant subunitspositioned adjacent rim 44. In some embodiments, secondary implants mayserve a role in minimizing risk of displacement of implant subunitspositioned adjacent rim 44. In some embodiments, one or more secondaryimplant subunits may help guide positioning of implant subunitspositioned adjacent rim 44.

For example, one or more secondary implant subunits may be placed overinterior portions 46 of exposed upper surface 42. Implant subunits maythen be positioned around the one or more secondary implant subunits,and tightening of cables may force the implant subunits to adopt aproper position around the secondary implant subunits. In someembodiments, secondary implant subunits may be made from one or morehighly porous materials and may be configured to promote osteogenesis,for example.

In some embodiments, two or more implant subunits among a plurality ofimplant subunits may be sized for insertion and configured for effectivepositioning when forming an implant. For example, two or more implantsubunits may be inserted and generally positioned within wedge-shapedvoid 10. Further positioning of the two or more implant subunits maythen be achieved when a surgeon directs the two or more implant subunitstogether. For example, in some embodiments, a surgeon may direct two ormore implant subunits together when tightening one or more cables. Insome embodiments, correct alignment of the two or more implant subunitsfor proper positioning during implant assembly may be encouraged becausethe two or more implant subunits may possess a complementary shape. Forexample, as shown in FIG. 10, a first implant subunit 64 may include oneor more surface features 66 that may be complementary in shape with oneor more surface features 68 present on another surface of an adjacent orsecond implant subunit 70. For example, complementary features 66, 68 ofthe surfaces 72, 74 may help guide the surfaces 72, 74 to abut togetherin a correct orientation when a surgeon directs the surfaces to contacteach other. For example, a surgeon may direct the surfaces 72, 74 tocontact each other by pulling on one or more cables and/or inserting oneor more screws or pins (not shown). By way of nonlimiting example,complementary features herein may include grooves, slots, ridges, othersuitable shapes, and any combinations thereof. In some embodiments,positioning and securing of implant subunits may be achieved at aboutthe same time or in a single step when a surgeon engages one or morecables and/or inserts one or more screws or pins in order to forceadjacent subunits together. In some embodiments, one or morecomplementary features may be included on one or more secondary implantsubunits such as secondary implant subunit 71 shown in FIG. 10.

FIG. 11 shows another embodiment of a generally U-shaped implant 76which may be constructed from a plurality of implant subunits. Forexample, seven separate implant subunits may be used to constructU-shaped implant 76, including lateral anterior implant subunit 78,central anterior implant subunit 80, and medial anterior implant subunit82. In addition, U-shaped implant 76 may include lateral posteriorimplant subunit 84, central posterior implant subunit 86, medialposterior implant subunit 88, and medial interior implant subunit 90. Asillustrated in the embodiment of U-shaped implant 76, implant subunitsmay include one or more walls defining an overall shape of an implantsubunit. The implant subunits may further include one or more internalcavities. In some embodiments, one or more internal walls or supportsmay further be included in an implant subunit. Other suitable numbersand arrangements of implant subunits may be included in a wedge-shapedimplant. For example, a generally U-shaped implant may have betweenabout 3 implant subunits to about 16 implant subunits or anothersuitable number and arrangement of subunits may be used.

In some embodiments, a space between individual subunits may be filledwith a filling material, such as a matrix material of bony fragments orother material to encourage osteogenesis, for example. In someembodiments, as shown in FIG. 12, a space between implant subunits (78,80, 82, 84, 86, 88, and 90) may be filled with one or more secondaryimplant subunits 92. Thus, generally U-shaped implant 76 may, in someembodiments, function as a U-shaped portion of an implant. The implantsubunit 92, which may not be in contact with hard cortical bone of rim44, may be under reduced stress as compared to other implant subunits(e.g., (78, 80, 82, 84, 86, 88, and 90) positioned adjacent rim 44 ofcortical bone. In some embodiments, the implant subunit 92 may be madeof a material such as a biocompatible plastic or metal that is lessexpensive than implant subunits (78, 80, 82, 84, 86, 88, and 90). Or, amaterial for implant subunit 92 may be selected based on other desiredcharacteristics, such as an ability to promote osteogenesis, healing, orto help minimize a risk of infection. FIG. 12A shows an additionalembodiment of a ring-shaped implant 77. Ring-shaped implant 77 mayinclude subunits (79, 81, 83, 85, 87, 89, and 91). In some embodiments,ring-shaped implant 77 may be used to provide substantially continuousand complete coverage of cortical bone of rim 44, including, forexample, near implant side 99 which may, for example, abut against hingeportion 48, if present.

FIG. 13 shows an additional embodiment of an implant 94. Implant 94 maycomprise three implant subunits, including anterior implant subunit 96,posterior implant subunit 98, and interior implant subunit 100. Notably,the implant subunits 96, 98, and 100 may include a substantially longerlength than a width. A surgeon may choose to insert the implant subunits96, 98, and 100 through an opening 34 and within a wedge-shaped void 10of the tibia 12 in an orientation to minimize a cross-sectional areasubtended by the implant subunits 96, 98, and 100 during insertionand/or to minimize a need for repositioning following insertion. In someembodiments, one or more of the implant subunits 96, 98, and 100 mayinclude one or more features suitable for grasping by a surgeon tofacilitate insertion in a specific orientation. For example, one or moreof the implant subunits 96, 98, and 100 may include one or more holes,notches, indents, or handles suitably configured so that a surgeon maygrasp an implant subunit 96, 98, and 100 with a pair of graspers orother surgical instruments. For example, FIG. 14 shows anterior implantsubunit 96 separated from the other implant subunits 98, 100. In someembodiments of a method for insertion of generally U-shaped implant 94,a surgeon may insert the subunit (as shown by insertion arrow 38)through the opening 34 about as oriented in FIG. 14, such that an areasubtended by the implant subunit 96 is generally minimized so as to fitthrough opening 34. To facilitate insertion, implant subunit 96 mayinclude a pair of indents 102 positioned towards a medial end of implantsubunit 96 that are configured to be grasped by graspers or anothersurgical instrument, for example.

FIG. 15 shows an embodiment of an implant subunit 104. Implant subunit104 may comprise medial endwall 106, lateral endwall 108, top wall 110,bottom wall 112, first sidewall 114, and second sidewall 116. The walls(e.g., 106, 108, 110, 112, 114, and 116) of implant subunit 104 may beshaped in the form of a square, rectangle, rhombus, parallelogram,trapezoid or other suitable geometric shape. For example, medial endwall106 and medial endwall 108 may be shaped as rectangles. In someembodiments, one or more of top wall 110 or bottom wall 112 may beoriented at an angle θ relative to a normal vector (shown as a dot-dashline in FIG. 15) of an adjacent endwall 106 or 108. For example, anangle θ may be suitable so that when implant subunit 104 is positionedwithin wedge-shaped void 10, the walls 110, 112 may follow a tapergenerally matched to wedge-shaped void 10. For example, in someembodiments, the angle θ may vary from about 7 degrees to about 15degrees. Similarly, one or more of first sidewall 114 and secondsidewall 116 may be oriented at an angle relative to a normal vector ofan adjacent endwall 106 or 108. Accordingly, one or more of thesidewalls 114, 116 may be oriented to generally form a generallyU-shaped implant including implant subunit 104 in an inward taper.

As shown in FIG. 15, one or more of the walls (106, 108, 110, 112, 114,and 116) of implant subunit 104 may include an opening 118. For example,implant subunit 104 may, at least in part, be hollow. In someembodiments, implant subunit 104 may be porous. Remaining portions of ahollow or porous implant subunit 104 may be configured to bearstructural loads from a patient's weight that may be transmitted throughthe tibia. For example, remaining portions of a hollow or porous implantsubunit 104 may comprise a cage suitably configured to bear structuralloads from a patient's weight that are transmitted through the tibia.The remaining portions of subunit 104 may comprise a scaffold configuredat a density and material composition suitable to withstand forcesassociated with a patient's weight when used with other implant subunitsin an implant. For example, a substantially hollow implant subunit 104may be used with other substantially hollow implants to form an implantor portion of an implant that may be positioned over at least an exposedrim of cortical bone of a patient's tibia when inserted into awedge-shaped void of the patient's tibia. A scaffold of sufficientdensity and suitable material composition (e.g., carbon-fiber orcarbon-fiber reinforced PEEK) may be used to support even obese patientswho may weigh upwards to about 300 pounds to about 500 pounds, forexample. In some embodiments, implants described herein may be filledwith one or more biocompatible materials. And, in some embodiments,implants described herein may transfer a portion of a weight of apatient to one or more materials filled within an otherwise hollowportion of implant subunit 104. For example, an otherwise hollow implantsubunit 104 may be filled with one or more materials suitable to promoteprocesses including osteogenesis, osteoinduction, osteoconduction, andany combination thereof. For example, hollow portions of an implantsubunit may be filled with demineralized bone matrix, hydroxyapatite,one or more growth factors, other suitable matrix materials, and anycombination thereof. By way of nonlimiting example, growth factorssuitable for use herein may include Transforming Growth Factor “TGF-B,”Platelet-Derived Growth Factor “PDGF,” Bone-Morphogenic Protein “BMP,”and any combination thereof.

Implant subunits described herein may be made from or may include anysuitable biologically compatible material or combination of materials.For example, suitable materials may be selected based on one or more ofthe following characteristics, or other characteristics, includingstrength, stiffness, biocompatibility, elasticity, and combinationsthereof. By way of nonlimiting example, suitable materials for use inimplant subunits described herein may include titanium, stainless steel,tantalum, suitable plastics, ceramics, metallic alloys including one ormore biologically compatible metals, biocompatible polymers (e.g.,polyethylethylketone (PEEK)), carbon-fiber, carbon-fiber reinforcedPEEK, and combinations thereof. In some embodiments, implant subunitsmay be made from, comprise, or consist of carbon-fiber or carbon-fiberreinforced PEEK.

Additional embodiments of implant subunits are also shown in FIGS.16-20. As shown in FIG. 16, an implant subunit 120 may include one ormore curved or shaped walls 122. For example, a curved or shaped wall122 may be configured to substantially match or trace one or moreadjacent surfaces of a patient's bone. As shown in FIG. 17, an implantsubunit 124 may be shaped to substantially fill an end of a wedge-shapedvoid 10. Thus, for example, one or more walls, such as sidewall 126 andtop wall 128 of an implant subunit 124 may be substantially triangularin shape. In some embodiments, implant subunit 124 may include one ormore rounded edges. For example, edge 130 or edge 132 may be rounded. Asshown in FIG. 18, an implant subunit 140 may include one or more holes142 and/or one or more hooks 144. The one or more holes 142 and/or hooks144 may be configured to receive one or more pins 146 or cables 148.Alternatively, holes 142 may be threaded, and threaded screws may beused instead of pins 146. In some embodiment, holes may include one ormore guiding bores or posts to assist a surgeon in threading a pin 146or screw through a hole. In some embodiments, one or more cables 148 maybe pre-threaded (e.g., within one or more holes 142 or through hooks144) within an implant subunit 140 prior to insertion of implantsubunit. In some embodiments, one or more holes 142 and/or hooks 144 maybe positioned on an implant subunit so that a surgeon may readily attacha pin 146, cable 148, or screw. For example, hole 142 may be positionedon an edge 143 that may be more centrally located in a generallyU-shaped implant.

As shown in FIG. 19, a pin 146 may be inserted into or through two ormore implant subunits 150, 152 in order to link the implant subunits150, 152 together. As shown in FIG. 20, a pin 146 may extend through twoor more implant subunits 150, 152 and also into or through a portion ofbone 154.

In some embodiments, kits are described herein which may include one ormore components or component types which may be used in a tibialosteotomy and repair. In some embodiments, a kit may include a pluralityof implant subunits, the implant subunits configured to form a generallyU-shaped implant when the implant subunits are used collectively. Thekit may further include one or more linking or stabilizing membersconfigured to physically link the plurality of implant subunits. Forexample, the kit may include one or more screws, pins, cables, crimpingassemblies, wires or combinations thereof as linking members. Forexample, as shown in FIG. 21, a kit 160 may include an assembly of fiveimplant subunits (162, 164, 166, 168, and 170). Kit 160 may furtherinclude a collection of cables 172 and one or more associated crimps174. For example, cables 172 may be configured for threading through oneor more internal holes 174 formed within the implant subunits (162, 164,166, 168, and 170). A kit may further include instructions for executingone or more of the surgical methods described herein. For example, a kit160 may include ordered instructions for how to insert, position, andlink the plurality of implant subunits (162, 164, 166, 168, and 170) inorder to assemble a generally U-shaped implant 176 as shown in FIG. 22.By way of nonlimiting example, instructions may be provided in the formof one or more computer readable media, printed instructions, orcombinations thereof.

In some embodiments, an implant may include one or more surfacesconfigured to substantially match a surface made by cutting and/orremoving a section of tibial bone. For example, the specific shape of animplant may be designed using one or more computer models and/orcomputer modeling techniques. For example, the shape of an implant maybe designed using one or more computer aided design (CAD) computerprograms. And, in some embodiments, the shape of an implant may bespecifically based on a patient's anatomy, such as may be obtained usingMRI and/or CT scanning techniques, for example.

FIG. 23 is a flowchart showing an embodiment of a method 200 forinserting an implant in a wedge-shaped void formed by an osteotomy. Instep 202, an opening in a patient's tissue may be made, wherein theopening is suitable to expose a portion of the patient's tibia. Forexample, an opening of limited size, such as a size appropriate forinsertion of implant subunits, may be made in the patient's tissue. Insome embodiments, the opening may be smaller than necessary for asurgeon to fit a prefabricated U-shaped or wedge-like implant therein.In step 204, a portion of a patient's tibia bone may be cut and openedin order to create a wedge-shaped void in the tibia. Or, a portion oftibia bone may be cut and removed to form a wedge-shaped void in thetibia. In step 206, each of a plurality of implant subunits may beinserted through the opening in the patient's tissue, and the pluralityof implant subunits may be positioned within the wedge-shaped void inorder to create an implant.

FIG. 24 is a flowchart showing an additional embodiment of a method 210for inserting an implant in an osteotomy. In step 212, an opening in apatient's tissue may be made, wherein the opening is suitable to exposea portion of the patient's tibia. For example, an opening of limitedsize, such as a size appropriate for insertion of implant subunits, maybe made in the patient's tissue. In some embodiments, the opening may besmaller than necessary for a surgeon to fit a prefabricated U-shapedimplant or wedge-like implant therein. In step 214, a portion of apatient's tibia bone may be cut and opened in order to create awedge-shaped void in the tibia. Or, a portion of tibia bone may be cutand removed to form a wedge-shaped void in the tibia. In step 216, eachof a plurality of implant subunits may be inserted within the opening inthe patient's tissue, the plurality of implant subunits may bepositioned within the wedge-shaped void, and two or more of theindividual implant subunits may be linked in order to create an implant.

In some embodiments, positioning of implant subunits in the steps 206,216 may include attaching, such as by internally threading, one or morecables or wires to one or more implant subunits among a plurality ofimplant subunits. A surgeon may then pull or tighten the one or morecables or wires in order to automatically position the one or moreimplant subunits in relation to other subunits in order to assemble animplant. Once positioned, a cable or wire may be crimped or otherwisesecured to maintain the desired position and to link the subunitstogether. Alternatively, the one or more cables or wires may simply beremoved. For example, a positioning guide wire may be used to position aplurality of implant subunits in order to assemble an implant. Once theimplant subunit is positioned, the guide wire may be removed.

In some embodiments, positioning of implant subunits in the steps 206,216 may include inserting one or more secondary implant subunits andgenerally positioning one or more implant subunits along a periphery ofthe one or more secondary implant subunits. Once generally positioned asurgeon may engage one or more cables to automatically position implantsubunits in a position adjacent the one or more secondary implantsubunits. To assist in orienting the implant subunits, adjacent implantsubunits may include one or more surface features to direct implantsurfaces in correct relative alignment.

In some embodiments, positioning of the plurality of implant subunitsmay include manual manipulation of individual subunits. For example, asurgeon may individually move individual subunits to a desired position,such as along a rim of cortical bone using one or more surgicalinstruments, such as surgical graspers.

Persons of ordinary skill in the art will understand that implantsubunits described herein may be positioned adjacent each other suchthat a given subunit touches one or more other subunits, or in someembodiments a given subunit may be spaced apart from other subunits.Additionally, whether a given subunit is adjacent or spaced apart withrespect to another subunit, the given subunit may or may not be linkedto one or more other subunits.

In some embodiments, an implant may be configured for insertion into awedge-shaped void of a patient's tibia, the implant including aplurality of implant subunits configured to form a generally U-shapedportion of the implant in plan view when the plurality of implantsubunits are positioned with respect to each other. The generallyU-shaped portion may have a generally wedge-shaped thickness profile.One or more cables may be configured for engaging at least some of theplurality of implant subunits. The one or more cables may be configuredsuch that when the one or more cables are tightened, the plurality ofimplant subunits may be automatically positioned to stabilize theimplant. In some embodiments, one or more implant subunits among theplurality of implant subunits may include a hole configured forreceiving of a pin or screw, the pin or screw configured to attach theone or more implant subunits to a portion of a patient's bone. Forexample, two or more implant subunits among the plurality of implantsubunits may include a hole configured for receiving of a pin or screw,the pin or screw configured to link the two or more implant subunitstogether. The one or more cables may be secured to at least some of theplurality of implant subunits using one or more fastener, hole, hook, orany combination thereof. In some embodiments, the one or more cables mayinclude a first cable configured for engagement with a first group ofimplant subunits among the plurality of implant subunits and a secondcable configured for engagement with a second group of implant subunitsamong the plurality of implant subunits. Each of the first and secondcables may include a free end that protrudes from a medial side of thegenerally U-shaped portion. One or more of the plurality of implantsubunits may be made of carbon-fiber or carbon-fiber reinforced PEEK.One or more of the plurality of implant subunits may include asubstantially hollow carbon-cage. In some embodiments, a first member ofthe plurality of implant subunits may include a first surface that iscomplementary in shape to a second surface of a second member among theplurality of implant subunits. The first surface and the second surfacemay be configured to automatically orient the first member and thesecond member in an orientation suitable for forming the generallyU-shaped portion of an implant when the one or more cables aretightened. The implant may include one or more secondary implantsubunits. The one or more secondary implant subunits may be made of amaterial including, for example, titanium, stainless steel, tantalum,plastic, ceramic, metal alloy, biologically compatible metal,biocompatible polymer, and any combination thereof.

In some embodiments, a kit for performing a surgical tibia repair mayinclude a plurality of implant subunits. The plurality of implantsubunits may be configured for arrangement with respect to one anotherto form a generally U-shaped portion of an implant in plan view, thegenerally U-shaped portion having a generally wedge-shaped thicknessprofile. The kit may further include one or more linking members andinstructions for how to assemble the plurality of implant subunits intothe implant using the one or more linking members. One or more of theplurality of implant subunits may be made of carbon-fiber orcarbon-fiber reinforced PEEK. The plurality of implant subunits mayinclude a substantially hollow carbon-cage.

In some embodiments, a kit for performing a surgical tibia repair mayinclude a plurality of implant subunits. The plurality of implantsubunits may be configured for arrangement with respect to one anotherto form an implant shaped to substantially cover an exposed rim ofcortical bone adjacent a wedge-shaped void in a patient's tibia. The kitmay also include one or more linking members and instructions for how toconnect the plurality of implant subunits to the one or more linkingmembers and how to automatically position the implant subunits to formthe implant when tightening the one or more linking members. Theplurality of implant subunits may include a plurality of implantsubunits configured for bearing a patient's weight. The plurality ofimplant subunits for bearing the patient's weight may include asubstantially hollow carbon-cage. In some embodiments, the plurality ofimplant subunits may include one or more secondary implant subunits. Theone or more secondary implant subunits may be configured for positioningover an exposed region of trabecular bone adjacent the wedge-shapedvoid. The one or more secondary implant subunits may be sized and shapedfor positioning over an exposed region of trabecular bone adjacent awedge-shaped void. The one or more secondary implant subunits may assistin positioning a generally U-shaped portion of the plurality of implantsubunits over the exposed rim of cortical bone when tightening the oneor more linking members. The one or more secondary implant subunits maybe sized and angled for positioning over an exposed region of trabecularbone adjacent the wedge-shaped void. At least one of the one or moresecondary implant subunits may include at least one surface that iscomplementary in shape to at least one other surface included in atleast one of the plurality of implant subunits.

In some embodiments, a method of installing an orthopedic implant mayinclude creating an opening in a patient's tissue in order to expose aportion of the patient's tibia and cutting a portion of the patient'stibia to create a wedge-shaped void therein. The method may furtherinclude individually inserting each of a plurality of implant subunitsthrough the opening in the patient's tissue and positioning theplurality of implant subunits within the wedge-shaped void to form agenerally U-shaped portion of the implant. In some embodiments,positioning the plurality of implant subunits may include generallypositioning the plurality of implant subunits on an exposed surface ofthe patient's tibia adjacent the wedge-shaped void, securing one or morecables to at least some of the plurality of implant subunits, andtightening the one or more cables to automatically direct the pluralityof implant subunits to form the generally U-shaped portion. Thegenerally U-shaped portion may substantially overlap an exposed rim ofcortical bone of the exposed surface of the patient's tibia. Two or moreof the plurality of implant subunits may further be linked. In someembodiments, the plurality of implant subunits may include one or moresecondary implant subunits and a plurality of other implant subunits. Inthose embodiments, positioning the plurality of implant subunits mayinclude generally positioning the plurality of implant subunits on anexposed surface of the patient's tibia adjacent the wedge-shaped void.For example, the one or more secondary implants may be generallypositioned over a trabecular portion of the exposed surface. Theplurality of other implant subunits may further be generally positionedalong a periphery of the one or more secondary implant subunits.Positioning the plurality of implant subunits may then include securingone or more cables to the plurality of other implant subunits andtightening the one or more cables to automatically direct the pluralityof other subunits to abut against at least one of the one or moresecondary implant subunits to form the generally U-shaped portion. Thegenerally U-shaped portion may substantially overlap an exposed rim ofcortical bone of the exposed surface of the patient's tibia. Forexample, the generally U-shaped portion may overlap an area that isgreater than about 75% of an area of the exposed rim of cortical bone.

In some embodiments, an implant may be configured for insertion into awedge-shaped void of a patient's tibia. The implant may include aplurality of implant subunits, the plurality of implant subunitsconfigured to shape the implant to substantially fill the wedge-shapedvoid when the plurality of implant subunits are positioned with respectto each other. One or more of the plurality of implant subunits mayinclude a substantially hollow carbon-cage made of carbon-fiber orcarbon-fiber reinforced PEEK. The implant may have a generallywedge-shaped thickness profile. The implant may, for example, beselected from a generally U-shaped implant and a ring-shaped implant. Insome embodiments, the implant may further include one or more cablesconfigured for engaging at least some of the plurality of implantsubunits. The one or more cables may be configured such that when theone or more cables are tightened, the plurality of implant subunits isautomatically positioned to form the implant. In some embodiments, theimplant may further include one or more cables and one or more pins orscrews. The one or more cables may be configured for engaging at leastsome of the plurality of implant subunits, the one or more cablesconfigured such that when the one or more cables are tightened theplurality of implant subunits is automatically stabilized. Each of oneor more implant subunits among the plurality of implant subunits mayinclude a hole configured for receiving at least one screw or pin amongthe one or more pins or screws. The one or more pins or screws mayfurther be configured to attach the one or more implant subunits to aportion of the patient's bone. In some embodiments, two or more implantsubunits among the plurality of implant subunits may include a holeconfigured for receiving of a pin or screw, the pin or screw configuredto link the two or more implant subunits together. In some embodiments,the implant may include one or more cables configured for engaging atleast some of the plurality of implant subunits, the one or more cablesincluding a first cable configured for engagement with a first group ofimplant subunits among the plurality of implant subunits and a secondcable configured for engagement with a second group of implant subunitsamong the plurality of implant subunits. Each of the first cable and thesecond cable may include a free end that protrudes from a medial side ofthe implant. In some embodiments, the implant may include one or morecables configured for engaging at least some of the plurality of implantsubunits, a first member of the plurality of implant subunits includinga first surface that is complementary in shape to a second surface of asecond member among the plurality of implant subunits. The first surfaceand the second surface may be configured to automatically orient thefirst member and the second member in an orientation suitable forforming the implant when the one or more cables are tightened. In someembodiments, the implant may include a first group of implant subunitsand a second group of implant subunits. The first group of implantsubunits being the one or more of said plurality of implant subunitsthat comprise the substantially hollow carbon-cage made of carbon-fiberor carbon-fiber reinforced PEEK, the first group of implant subunitsshaped to be positioned over an exposed rim of cortical bone of apatient's tibia when inserted into said wedge-shaped void of thepatient's tibia. The second group of implant subunits being one or moresecondary implant subunits sized and shaped for positioning over anexposed region of trabecular bone of a patient's tibia when insertedinto the wedge-shaped void of the patient's tibia. The one or moresecondary implant subunits may be made of or include a material selectedfrom titanium, stainless steel, tantalum, plastic, ceramic, metal alloy,biologically compatible metal, biocompatible polymer, and anycombination thereof.

Although the methods, kits, and apparatus disclosed herein and some oftheir advantages have been described in detail, it should be understoodthat various changes, substitutions and alterations may be made hereinwithout departing from the invention as defined by the appended claimsand their legal equivalents. For example, among other things, anyfeature described for one embodiment may be used in any otherembodiment, and any feature described herein may be used independentlyor in combination with other features. Moreover, the scope of thepresent application is not intended to be limited to the particularembodiments of the apparatuses, kits, methods and steps described in thespecification. Use of the word “include,” for example, should beinterpreted as the word “comprising” would be, i.e., as open-ended. Asone will readily appreciate from the disclosure, processes, machines,manufactures, compositions of matter, means, methods, or steps presentlyexisting or later to be developed that perform substantially the samefunction or achieve substantially the same result as the correspondingembodiments described herein may be utilized. Accordingly, the appendedclaims are intended to include within their scope such processes,machines, manufactures, compositions of matter, means, methods or steps.

What is claimed is:
 1. A kit for performing a surgical tibia repair, thekit comprising: a plurality of implant subunits; wherein said pluralityof implant subunits are configured for arrangement with respect to oneanother to form an implant shaped to substantially cover an exposed rimof cortical bone adjacent a wedge-shaped void in a patient's tibia; oneor more linking members; and instructions for how to connect saidplurality of implant subunits to said one or more linking members andhow to automatically position said implant subunits to form said implantwhen tightening said one or more linking members; wherein said pluralityof implant subunits include a plurality of implant subunits configuredfor bearing a patient's weight, said plurality of implant subunitscomprising a substantially hollow carbon-cage.
 2. The kit of claim 1wherein said plurality of implant subunits include one or more secondaryimplant subunits.
 3. The kit of claim 2 wherein said one or moresecondary implant subunits are configured for positioning over anexposed region of trabecular bone adjacent the wedge-shaped void.
 4. Thekit of claim 2 wherein said one or more secondary implant subunits aresized and shaped for positioning over an exposed region of trabecularbone adjacent said wedge-shaped void; wherein said one or more secondaryimplant subunits assist in positioning a generally U-shaped portion ofsaid plurality of implant subunits over said exposed rim of corticalbone when tightening said one or more linking members.
 5. The kit ofclaim 2 wherein said one or more secondary implant subunits are sizedand angled for positioning over an exposed region of trabecular boneadjacent said wedge-shaped void; wherein at least one of said one ormore secondary implant subunits includes at least one surface that iscomplementary in shape to at least one other surface included in atleast one of said plurality of implant subunits.